Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup

Q: Who is the manufacturer of Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

Healgen Scientific,, LLC filed the 510(k) submission for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (K243365).

Q: What is the FDA product code for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

NGL. It is classified under 21 CFR 862.3650 as a Class 2 device in the Clinical Toxicology panel.

Q: What is the regulatory pathway for Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K243365 · Healgen Scientific,, LLC · NGL · Dec 17, 2024 · Clinical Toxicology

Device Facts

Record ID	K243365
Device Name	Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
Applicant	Healgen Scientific,, LLC
Product Code	NGL · Clinical Toxicology
Decision Date	Dec 17, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3650
Device Class	Class 2

Intended Use

The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: [Table omitted for brevity]. The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs [Table omitted for brevity]. This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.

Device Story

Lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Device format: cup with integrated test strips. Principle: competitive binding; drug in urine competes with drug-protein conjugate for limited monoclonal antibody binding sites. Negative result: colored line in Test Region (T) (drug below cutoff). Positive result: absence of colored line in Test Region (T) (drug at/above cutoff). Control line (C) confirms proper procedure. Used in clinical or home settings; operated by clinicians or lay users. Provides preliminary results; requires confirmatory testing (GC-MS/LC-MS) for clinical decision-making. Benefits: rapid, qualitative screening for drug presence.

Clinical Evidence

Bench testing only. Precision/reproducibility studies performed over 25 days. Analytical specificity/interference testing evaluated cross-reactivity and potential interfering substances. Method comparison study against LC-MS/MS using 80 clinical samples per drug. Lay-person study with 280 participants confirmed ease of use and performance across diverse demographics.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Materials: chromatographic absorbent device, mouse monoclonal antibody conjugates. Form factor: cup. Stability: 36 months at 2-30°C. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative detection of drugs of abuse (18 analytes including amphetamines, opioids, cocaine, etc.) in human urine. Intended for prescription or over-the-counter use to provide preliminary screening results. Requires confirmatory testing via GC-MS or LC-MS.

Regulatory Classification

Identification

An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Related Devices

K260355 — Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine Cup · WEBEST Biotech,, LLC · Mar 9, 2026
K250727 — AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Apr 4, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ December 17, 2024 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Healgen Scientific LLC % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877 Re: K243365 Trade/Device Name: Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL,NFT,PTH,NFY,NFV,PTG,NGG,NGM,QBF,QAW,NFW Dated: October 26, 2024 Received: October 29, 2024 Dear Jenny Xia: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/2/Picture/3 description: The image shows the name Joseph A. Kotarek -S. It also shows that the document was digitally signed by Joseph A. Kotarek -S on December 17, 2024. The time stamp on the document is 10:21:47 -05'00'. Joseph Kotarek Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243365 #### Device Name Healgen® Accurate Muti-Drug Urine Drug Screen Cup; Healgen® Accurate Home Muti-Drug Urine Test Cup #### Indications for Use (Describe) The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamine, Mortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |------------|------------------------------------------------------|-----------------| | 6-MAM | 6-Monoacetylmorphine | 10 | | AMP | d-Amphetamine | 500 or 1000 | | BAR | Secobarbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 150 or 300 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrolidine | 300 | | FEN or FYL | Norfentanyl | 5 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | d-Methamphetamine | 500 or 1000 | | MTD | Methadone | 300 | | OPI | Morphine | 300 or 2000 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | d-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | | TRA or TMI | Tramadol | 100 | The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of one or more of the following drugs | CODE | SUBSTANCE | Cut-off (ng/mL) | |------|---------------|-----------------| | AMP | Amphetamine | 1000 or 500 | | BUP | Buprenorphine | 10 | | BAR | Secobarbital | 300 | | BZO | Oxazepam | 300 | | COC | Cocaine | 300 or 150 | | EDDP | EDDP | 300 | {4}------------------------------------------------ | FYL | Norfentanyl | 5 | |----------|----------------------|-------------| | MET/mAMP | Methamphetamine | 1000 or 500 | | MDMA | Ecstasy | 500 | | OPI | Morphine | 2000 or 300 | | MTD | Methadone | 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | Marijuana | 50 | | TML | Tramadol | 100 | | 6-MAM | 6-Monoacetylmorphine | 10 | This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ # 510(k) SUMMARY K243365 | 1. Date: | October 29, 2024 | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. Submitter: | Healgen Scientific LLC. 3818 Fuqua Street Houston, TX 77047 | | 3. Contact person: | Jenny Xia LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 301-525-6856 Email: jxia@lsi-consulting.org | | 4. Device Name: | Healgen® Accurate Muti-Drug Urine Drug Screen Cup Healgen® Accurate Home Muti-Drug Urine Test Cup | #### 5. Classification: Class II | Product Code Target Drug | Regulation Section | Panel | |---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|------------| | NFT Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology | | PTH Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology | | NGL Buprenorphine (BUP) Morphine (OPI) Oxycodone (OXY) 6-Monoacetylmorphine(6-MAM) Norfentanyl (FEN) Tramadol (TML) | 862.3650, Opiate Test System | Toxicology | | NFV Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology | | NFY Cocaine (COC) | 862.3250, Cocaine and cocaine metabolite test system | Toxicology | | PTG 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP) Methadone (MTD) | 862.3620, Methadone Test System | Toxicology | | NGG | 862.3610, Methamphetamine Test System | Toxicology | {6}------------------------------------------------ | Methylenedioxymethamphetamine (MDMA) Methamphetamine (MET) | | | |------------------------------------------------------------------|--------------------------------------------------------|------------| | NGM Phencyclidine (PCP) | Unclassified | Toxicology | | QBF Propoxyphene(PPX) | 862.3700 Propoxyphene test system. | Toxicology | | QAW Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant drugs test system | Toxicology | | NFW Cannabinoids (THC 50) | 862.3870, Cannabinoids Test System | Toxicology | #### Predicate Devices: 6. Healgen Accurate Urine Drug Screen Dip Card (K240686) #### 7. Intended Use The Healgen® Accurate Multi-Drug Urine Screening Cup is a rapid lateral flow immunoassay for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, Norfentanyl, Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, Tramadol in human urine. The test cut-off concentrations and the compounds the THC-COOH and tests are calibrated to are as follows: | Test | Calibrator | Cut-off (ng/mL) | |------------|--------------------------------------------------|-----------------| | 6-MAM | 6-Monoacetylmorphine | 10 | | AMP | d-Amphetamine | 500 / 1000 | | BAR | Secobarbital | 300 | | BUP | Buprenorphine | 10 | | BZO | Oxazepam | 300 | | COC | Benzoylecgonine | 150 / 300 | | EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 | | FEN or FYL | Norfentanyl | 5 | | MDMA | Methylenedioxymethamphetamine | 500 | | MET | d-Methamphetamine | 500 / 1000 | | MTD | d/l-Methadone | 300 | | OPI | Morphine | 300 / 2000 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | d-Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | 11-nor-Δ9-THC-COOH | 50 | {7}------------------------------------------------ | TRA or TML | Tramadol | 100 | |------------|----------|-----| |------------|----------|-----| The single or multi-test cups can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT). The tests provide only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (CC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. The Healgen® Accurate Home Multi-Drug Urine Test Cup is a rapid qualitative immunoassay. | CODE | SUBSTANCE | CUT-OFF (ng/mL) | |----------|----------------------|--------------------| | AMP | Amphetamine | 1000 or 500 | | BUP | Buprenorphine | 10 | | BAR | Secobarbital | 300 | | BZO | Oxazepam | 300 | | COC | Cocaine | 300 or 150 | | EDDP | EDDP | 300 | | FYL | Norfentanyl | 5 | | MET/mAMP | Methamphetamine | 1000 or 500 | | MDMA | Ecstasy | 500 | | OPI | Morphine | 2000 or 300 | | MTD | Methadone | 300 | | OXY | Oxycodone | 100 | | PCP | Phencyclidine | 25 | | PPX | Propoxyphene | 300 | | TCA | Nortriptyline | 1000 | | THC | Marijuana | 50 | | TML | Tramadol | 100 | | 6-MAM | 6-Monoacetylmorphine | 10 | The device provides preliminary results for the detection of one or more of the following drugs. This drug test cup may contain any combination of the drug tests listed in the table above. This test provides only preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. #### 8. Device Description Healgen® Accurate Home Muti-Drug Urine Test Cup and Healgen® Accurate Muti-Drug Urine {8}------------------------------------------------ Drug Screen Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a cup format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use. | Similarities | | | |--------------------------------------|---------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Item | Device | Predicate (K240686) | | Intended use | Qualitative detection of drugs of abuse in urine. For prescription use or over-the-counter use | Same. | | Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen- antibody reaction | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human urine | Same | | Target Drug and Cut Off Values | Target Drugs | Cutoff (ng/mL) | | | Amphetamine(AMP) | 1000 or 500 | | | Secobarbital (BAR) | 300 | | | Buprenorphine (BUP) | 10 | | | Oxazepam (BZO) | 300 | | | Cocaine (COC) | 300 or 150 | | | 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP) | 300 | | | Norfentanyl | 5 | | | Methylenedioxymethamphetamine (MDMA) | 500 | | | Methamphetamine (MET) | 1000 or 500 | | | Morphine (MOP300/OPI2000) | 2000 or 300 | | | Methadone (MTD) | 300 | | | Oxycodone (OXY) | 100 | | | Phencyclidine (PCP) | 25 | | | Propoxyphene(PPX) | 300 | | | Nortriptyline (TCA) | 1000 | | | | Same except no Norfentanyl and Tramadol | #### Substantial Equivalence Information 9. {9}------------------------------------------------ | Cannabinoids (THC) | 50 | |-----------------------------|---------------| | 6-Monoacetylmorphine(6-MAM) | 10 | | Tramadol | 100 | | Differences | | | Configurations | | | Test cup | Test Dip Card | ## 10. Standard/Guidance Document Reference (if applicable) None referenced. ## 11. Test Principle Healgen® Accurate Home Muti-Drug Urine Test Cup or Healgen® Accurate Muti-Drug Urine Drug Screen Cup is a competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites. When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result. When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result. To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly. ## 12. Performance Characteristics ## A. Analytical performance ## a. Precision/Reproducibility: Precision studies were carried out for samples with concentrations of +100% cutoff, +75% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test cups with one operator per lot. The results obtained are summarized in the following tables: {10}------------------------------------------------ | Drug | Lot Number | +100% cutoff | +75% cutoff | +50% cutoff | +25% cutoff | Cutoff | -25% cutoff | -50% cutoff | -75% cutoff | -100% cut-off | |-------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------| | AMP 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | BAR 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | BUP 10 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 27-/23+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | BZO 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | COC 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | EDDP 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | FYL 5 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | MDMA 500 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | MET 1000 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | OPI 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | MTD 300 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | OXY 100 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | PCP 25 | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | | | | | | | | | | | PPX | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 300 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | TCA | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | 1000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | THC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | 50 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | TML | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 100 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | 6-MAM | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 26-/24+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 10 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | AMP | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | COC | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 150 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | MET | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | 500 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ | | OPI | Lot 1 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 26-/24+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | 2000 | Lot 2 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | | | Lot 3 | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | {11}------------------------------------------------ ### b. Linearity/assay reportable range: Not applicable. This device is intended for qualitative use only. ## c. Stability: The device is stable at 2-30°C for 36 months based on real time stability study. ## d. Analytical specificity/Interference: To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine samples were tested using three lots of the device. Percent cross-reactivity, provided in the below table, was calculated as the cutoff concentration divided by the concentration of analyte tested that yielded a positive result, multiplied by 100. {12}------------------------------------------------ | Drug/Cutoff | Compound | Minimum concentration required to obtain a positive result (ng/mL) | % Cross- Reactivity | |--------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------|------------------------| | AMP 1000 | Hydroxyamphetamine | 8000 | 12.5% | | | (+/-)- | 400 | 250% | | | Methylenedioxyamphetamine(MDA) | | | | | D,L-Amphetamine | 1,000 | 100% | | | D-Amphetamine | 1,000 | 100% | | | Diethylstilbestrol | 5,000 | 20% | | | L-Amphetamine | 50,000 | 2% | | | Phentermine | 8,000 | 12.5% | | | β-Phenylethylamine | 100,000 | 1% | | | Tyramine | 100,000 | 1% | | | p-Hydroxynorephedrine | 100,000 | 1% | | | D,L-Norephedrine | 100,000 | 1% | | | p-Hydroxyamphetamine | 100,000 | 1% | | | D-Methamphetamine | 100,000(Negative) | Not detected | | | L-Methamphetamine | 100,000(Negative) | Not detected | | | Ephedrine hydrochloride | 100,000(Negative) | Not detected | | | (+/-)3,4- | | | | | Methylenedioxymethamphetamine (MDMA) | 100,000(Negative) | Not detected | | | Phenylpropanolamine | 100,000(Negative) | Not detected | | | Benzphetamine | 100,000(Negative) | Not detected | | | L-Ephedrine | 100,000(Negative) | Not detected | | | L-Epinephrine | 100,000(Negative) | Not detected | | | D,L-Epinephrine | 100,000(Negative) | Not detected | | | (+/-)3,4- | | | | | Methylenedioxyethylamphetamine (MDEA) | 100,000(Negative) | Not detected | | | Alphenal | 150 | 200% | | BAR 300 | Amobarbital | 300 | 100% | | | Aprobarbital | 250 | 120% | | | Butabarbital | 2,500 | 12% | | | Butethal | 100 | 300% | | | Cyclopentobarbital | 600 | 50% | | | Pentobarbital | 250 | 120% | | | Phenobarbital | 250 | 120% | | | Secobarbital | 300 | 100% | | | Butalbital | 2,500 | 12% | | | Buprenorphine | 10 | 100% | | | Buprenorphine -3-D-Glucuronide | 160 | 6.25% | | | Norbuprenorphine | 10 | 100% | | BUP 10 | Norbuprenorphine-3-D-Glucuronide | 200 | 5% | | | Morphine | 100000 (Negative) | Not Detected | | | Oxymorphone | 100000 (Negative) | Not Detected | | | Hydromorphone | 100000 (Negative) | Not Detected | | | a-Hydroxyalprazolam | 1,260 | 23.8% | | | Alprazolam | 200 | 150% | | | Bromazepam | 1,560 | 19.2% | | | Chlordiazepoxide | 1,560 | 19.2% | | | Clobazam | 100 | 300% | | | Clonazepam | 2,500 | 12% | | | Clorazepate Dipotassium | 200 | 150% | | | Desalkylflurazepam | 400 | 75% | | | Diazepam | 200 | 150% | | BZO 300 | Estazolam | 2,500 | 12% | | | Flunitrazepam | 400 | 75% | | | D,L-Lorazepam | 1,560 | 19.2% | | | Midazolam | 12,500 | 2.4% | | | Nitrazepam | 100 | 300% | | | Norchlordiazepoxide | 200 | 150% | | | Nordiazepam | 400 | 75% | | | Oxazepam | 300 | 100% | | | Oxazepam glucuronide | 500 | 60% | | | R,S-Lorazepam glucuronide | 160 | 187.5% | | | Temazepam | 100 | 300% | | | Triazolam | 2,500 | 12% | | | Demoxepam | 2,000 | 15% | | | Flurazepam | 500 | 60% | | | Delorazepam | 100,000(negative) | Not detected | | COC 300 | Benzoylecogonine | 300 | 100% | | | Cocaethylene | 300 | 100% | | | Cocaine hydrochloride | 300 | 100% | | COC 300 | Ecgonine | 50,000 | 0.6% | | | Norcocaine | 100,000 | 0.3% | | | Ecgonine methyl ester | 100,000(negative) | Not detected | | | 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | 300 | 100% | | | Methadone | 100,000(negative) | Not detected | | | EMDP | 100,000(negative) | Not detected | | EDDP 300 | Doxylamine | 100,000(negative) | Not detected | | | Levacetylmethadol (LAAM) | 100,000(negative) | Not detected | | | Disopyramide | 100,000(negative) | Not detected | | | Alpha Methadol | 100,000(negative) | Not detected | | | Norfentanyl | 5 | 100% | | | Fentanyl | 10 | 50% | | | Acetyl fentanyl | 150 | 3.3% | | | Acetyl Norfentanyl | 200 | 2.5% | | | (+)-β-Hydroxythiofentanyl HCl | 2,500 | 0.2% | | | Acryl Fentanyl | 2,500 | 0.2% | | | Butyryl Fentanyl | 5,000 | 0.1% | | FYL 5 | Cis-d, I 3-Methylfentanyl | 50,000 | 0.01% | | | Furanyl Fentanyl | 10,000 | 0.05% | | | Para-fluoro butyrl Fentanyl (P-FBF) | 80,000 | 0.01% | | | Para-fluoro Fentanyl | 40,000 | 0.005% | | | 9-HydroxyRisperidone | 10,000 | 0.05% | | | Alfentanil | 20,000 | 0.03% | | | Isobutyryl Fentanyl | 5,000 | 0.1% | | | Trans-d. 1-3-Methylfentanyl | 50 | 10% | | | | | | | Norcarfentail Oxalate | 50,000 | 0.01% | | | Remifentanil | 15,000 | 0.03% | | | Valeryl Fentanyl | 20,000 | 0.03% | | | Thienyl Fentanyl | 50 | 10% | | | 4-Fluoro-isobutyryl Fentanyl | 20,000(Negative) | Not detected | | | Despropionyl fentanyl (4-ANPP) | 20,000(Negative) | Not detected | | | MT-45 | 100,000(Negative) | Not detected | | | Ocfentanil | 100,000(Negative) | Not detected | | | Risperidone | 100,000(Negative) | Not detected | | | Sufentanil | 100,000(Negative) | Not detected | | | Carfentanil Oxalate | 100,000(Negative) | Not detected | | | Labetalol Hydrochloride | 100,000(Negative) | Not detected | | | Trazodone | 100,000(Negative) | Not detected | | | U-47700 | 100,000(Negative) | Not detected | | | ω-1-Hydroxyfentanyl | 20,000(Negative) | Not detected | | | 6-Acetyl morphine | 100,000(Negative) | Not detected | | | Amphetamine | 100,000(Negative) | Not detected | | | Buprenorphine | 100,000(Negative) | Not detected | | | Buprenorphine -3-D-Glucuronide | 100,000(Negative) | Not detected | | | Codeine | 100,000(Negative) | Not detected | | | Dextromethorphan | 100,000(Negative) | Not detected | | | Dihydrocodeine | 100,000(Negative) | Not detected | | | EDDP | 100,000(Negative) | Not detected | | | EMDP | 100,000(Negative) | Not detected | | | Fluoxetine | 100,000(Negative) | Not detected | | | Heroin | 100,000(Negative) | Not detected | | | Hydrocodone | 100,000(Negative) | Not detected | | | Hydromorphone | 100,000(Negative) | Not detected | | | Ketamine | 100,000(Negative) | Not detected | | | Levorphanol tartrate | 100,000(Negative) | Not detected | | | Meperidine | 100,000(Negative) | Not detected | | | Methadone | 100,000(Negative) | Not detected | | | Morphine | 100,000(Negative) | Not detected | | | Morphine-3-β-D-Glucuronide | 100,000(Negative) | Not detected | | | | Naloxone hydrochloride | 100,000(Negative) | Not detected | | | Naltrexone hydrochloride | 100,000(Negative) | Not detected | | | Norbuprenorphine | 100,000(Negative) | Not detected | | | Norcodeine | 100,000(Negative) | Not detected | | | Norketamine | 100,000(Negative) | Not detected | | | Normeperidine | 100,000(Negative) | Not detected | | | Normorphine | 100,000(Negative) | Not detected | | | Noroxycodone | 100,000(Negative) | Not detected | | | Oxycodone | 100,000(Negative) | Not detected | | | Oxymorphone | 100,000(Negative) | Not detected | | | Pentazocine (Talwin) | 100,000(Negative) | Not detected | | | Pipamperone | 100,000(Negative) | Not detected | | | Tapentadol hydrochloride | 100,000(Negative) | Not detected | | | Thioridazine | 100,000(Negative) | Not detected | | | Tilidine | 100,000(Negative) | Not detected | | | Tramadol | 100,000(Negative) | Not detected | | | o-Desmethyl Tramadol | 100,000(Negative) | Not detected | | | n-Desmethyl Tramadol | 100,000(Negative) | Not detected | | MDMA 500 | (+/-)3,4- Methylenedioxymethamphetamine HCI(MDMA) | 500 | 100% | | | (+/-)3,4-Methylenedioxyamphetamine HCI (MDA) | 3,000 | 16.7% | | | (+/-)3,4- Methylenedioxyethylamphetamine (MDEA) | 300 | 167% | | | L-Methamphetamine | 50,000 | 1% | | | 7-Aminoclonazepam | 100,000 | 0.5% | | | d-methamphetamine | 100,000(Negative) | Not detected | | | d-amphetamine | 100,000(Negative) | Not detected | | | l-amphetamine | 100,000(Negative) | Not detected | | MET 1000 | (+/-)3,4-Methylenedioxy-n- ethylamphetamine (MDEA) | 20,000 | 5% | | | (+/-)3,4- | 2,500 | 40% | | | Methylenedioxymethamphetamine (MDMA) | | | | | D-Methamphetamine | 1,000 | 100% | | | L-Methamphetamine | 25,000 | 4% | | | Fenfluramine | 50,000 | 2% | | | p-Hydroxymethamphetamine | 10,000 | 10% | | | D,L-Methamphetamine | 1,000 | 100% | | | β-Phenylethylamine | 50,000 | 2% | | | Mephetermine | 50,000 | 2% | | | Methoxyphenamine hydrochloride | 50,000 | 2% | | | L-Amphetamine | 75,000 | 1.33% | | | D-Amphetamine | 100,000(Negative) | Not detected | | | D,L-Amphetamine | 100,000(Negative) | Not detected | | | Chloroquine | 100,000(Negative) | Not detected | | | Ephedrine hydrochloride | 100,000(Negative) | Not detected | | | (+/-)3,4-Methylenedioxyamphetamine (MDA) | 100,000(Negative) | Not detected | | | Trimethobenzamide | 100,000(Negative) | Not detected | | | l-phenylephrine | 100,000(Negative) | Not detected | | | (1R,2S)-(-)-Ephedrine | 100,000(Negative) | Not detected | | | Procaine hydrochloride | 100,000(Negative) | Not detected | | | 6-acetylmorphine | 2,500 | 80% | | | Codeine | 1,000 | 200% | | | Dihydrocodeine | 1,500 | 133.3% | | OPI 2000 | EthylMorphine | 2,500 | 80% | | | Codeine-6-β-D-glucuronide | 2,500 | 80% | | | Heroin | 5,000 | 40% | | | Hydrocodone | 5,000 | 40% | | | Hydromorphone | 2,500 | 80% | | | Levorphanol tartra…